Biotechnology to the Supreme Court: Will the US government support Amgen's petition?

Biotechnology to the Supreme Court: Will the US government support Amgen’s petition?

“After looking into the history of this case, and specifically Judge Andrews’ longtime application Chopsticks factors … leaving entitlement as a matter of law based on underlying facts may be the best course of action.

Earlier this year, we discussed Amgen’s petition for the Supreme Court’s review of the Federal Circuit’s claim that it invalidates several patent applications for antibodies based on lack of qualification for gender claims. At the time, we felt that Amgen had little chance of its petition going through, mainly because the Supreme Court denied a similar petition from Idenix in 2021 (# 20-380, January 19, 2021).

However, on April 18, the Supreme Court called on the Attorney General to file a pleading expressing the views of the US government on the issues presented. The probability of the Supreme Court to grant the cert. in each particular case it increases by about 10 times when the memory of an attorney general is requested, but more importantly, the Supreme Court follows the recommendation of the attorney general about 75% of the time. See P. Gugliuzza, “The Supreme Court Bar at the Bar of Patents”, Working Paper (2019) at 23. While every true handicap of cert. be granted in Amgen’s case will have to wait until the attorney general’s brief is filed later this year, meanwhile we are reminded of Jim Carrey’s joke from Dumber and dumber: “So you’re telling me there’s a possibility.”

Going back to Amgen’s first question presented in its petition, the question arises whether the licensing lends itself to a pure matter of fact or whether the current Federal Circuit standard (under which it is a matter of law based on fact underlying) is the correct interpretation. Interestingly, in footnote 2 to its petition, Amgen rejected the federal circuit panel’s attempt to compare licensing to the obvious. But given that both the qualification and the obvious call for complicated and multifactorial tests (the Chopsticks And Graham factors, respectively), the panel comparison seems to be spot on.

After reviewing the history of this case, and specifically Judge Andrews’ longtime application Chopsticks factors, 858 F.2d 731 (Fed. Cir. 1988), leaving the qualification as a matter of law based on underlying facts may be the best course of action.

Lack of licensing in the district court

The dispute between Amgen and Sanofi dates back to 2014, when Amgen claimed that Sanofi and Regeneron’s PCSK9 antibody product, Praluent® (alirocumab), which is approved by the Food and Drug Administration (FDA) to lower LDL (bad) cholesterol, has infringed several Amgen patents. In 2016, a first jury found that Amgen’s patents were invalid and infringed, but the federal circuit vacated and indicted, believing that evidence from the next priority date could be taken into account in assessing the authorization and the written description. See 872 F.3d 1367, 1373-75.

In 2019, a second jury again found Amgen’s patent invalid for written description and licensing. While the validity of the patent is ultimately a matter of law, questions of, for example, qualification and obviousness are based on detailed factual findings. In particular, the Amgen vs Sanofi the jury verdict form assessed disability with a single “yes” or “no” checkbox for each claim (see below). As a result, it was Judge Andrews, in his view, who upheld the post-trial motion for Sanofi’s Rule 50 who reviewed the minutes and produced factual conclusions to assess the Chopsticks factors in determining whether the amount of experimentation required to put the full scope of the claims into practice is “undue”. See CA 1: 14-cv-1317-RGA, DE 1050 a (D. Del. 28 August 2019).

In particular, Judge Andrews held that “a reasonable connoisseur” could only have held that: “the scope covered by the questions is broad”; “The structure-function relationship [for the claimed antibodies] it is unpredictable “; And “[a] a person of ordinary skill in the art may discover undisclosed claimed embodiments only (1) through trial and error, making modifications to the disclosed antibodies and then screening those antibodies for desired binding and blocking properties, or (2) discovering the antibodies de novo. ” Id. a * 13- * 21. As a result, the court found that “any reasonable fact-finding would consider that exercising the full scope of the claims would require substantial testing”, which was “undue” because, Moreovera person of ordinary skill in the art would be required to do almost exactly the same amount of work as the patent owner in order to identify additional antibodies within the full scope of the claims. Id. a * 23.

The affirmation of the federal circuit

In stating the district court’s lack of licensing, the Federal Circuit noted that “although Chopsticks gave birth to its eponymous factors, . . . [f]the control and, in this court, the auditing standard also acts. 987 F.3d 1080, 1086. The panel found that Amgen’s patent claims were similar to those held to be invalid in summary judgment in Wyeth (720 F.3d 1380) and Enzo (928 F.3d 1340), and in Idenix (941 F.3d 1149) based on a Rule 50 motion. Id.

In each of these cases, broad functional claims were deemed invalid based on a lack of predictability and direction that would require undue experimentation for a person of ordinary skill in the industry to practice the full scope of the claims. The jury further noted that “[w]Although the limitations of functional claims are not necessarily precluded in claims that satisfy the qualification requirement, such limitations place high obstacles in meeting the qualification requirement for claims with a broad functional language. Id. a 1087. The panel then reviewed Judge Andrews’ findings regarding the Chopsticks factors, not finding obvious errors in his analysis. Id. to 1087-88.


Amgen’s first application filed in its cert. frames the issue as another case in which the federal circuit has deviated from a statute, federal rules, or longstanding precedent:

  1. Whether the qualification is “a matter of fact to be determined by the jury”, Wood vs Underhill46 US (5 How.) 1, 4 (1846), as this Court held, or “a matter of law which [the court] revision[s] without deference ”, Pet. App. 6a, as claimed by the Federal Circuit.

But a deeper dive Wood vs Underhill reveals that the Supreme Court’s decision in that case is similar to the current qualification standard used by the Federal Circuit. The patent in question in Wood affirmed methods of making bricks and tiles using proportions of coal dust and clay, and the Supreme Court interpreted the qualification requirement as requiring that a patent specification “be in terms so full, clear, concise and exact as to allow to anyone skilled in the art who is responsible for composing and using it… without doing any experiments on their own “. 46 USA (5 Come) 1, 5-6 (1846).”[W]whether the fact is so or not is a question that must be decided by a jury, on the evidence of persons skilled in the art to which the patent belongs. Id. in point 6. More significantly, in overturning the district court’s conclusion of nullity for lack of qualification based on erroneous instructions to the jury “that the specification was too vague and uncertain to support the patent”, the Supreme Court also felt that “this [lack of enablement] does not appear to be the case on the face of this specification. Id. Therefore, the Supreme Court found by law that the disputed patent in Wood was enabled.

Looking back at the procedural history in Amgen vs Sanofithe analysis of the district court and the affirmation of the Federal Circuit appear in line with the seal of the Supreme Court Woodsince both the district court and the federal circuit have observed that disability due to lack of qualification is a matter of law supported by factual findings.

The Supreme Court, in fact, has repeatedly reiterated that the ultimate question of the validity of the patent remains a question of law. See Microsoft Corp. v. I4i Ltd. P’ship564 US 91, 96-97 (2011) (“Although the ultimate question of patent validity is of law, … the same factual issues underlying the original examination of a patent application by the PTO will also concern a defense of nullity in a counterfeiting action. “(citations omitted) (cit Graham v John Deere Co. of Kan. City383 USA 1, 17 (1966))).

Reformulation Woods instructions, there remains the requirement that the questions of fact supporting the determination of entitlement should be determined by a jury. However, as noted above, the jury’s verdict forms in Amgen vs Sanofi omitted any question concerning the factual basis of the qualification, such as the breadth of the statements, the sufficiency of the specification or the predictability in art.

Therefore, to the extent that pre-trial detention is required by Woodit would be a third jury trial with explicit instructions for the jury to review the Chopsticks factors and making factual findings. However, given that the jury form was negotiated by both Amgen and Sanofi, we see no reason to tax the Delaware courts with a third trial. Nor do we see anything wrong with the Supreme Court’s decision to maintain the status quo on licensing.

We look forward to the Attorney General’s brief later this year to see if the US government thinks the same about this case.

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